Activa Deep Brain Stimulation Therapy System
FDA premarket approval P960009/S329 · decided 2018-11-08
Approval details
- PMA number
- P960009
- Supplement
- S329
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Activa Deep Brain Stimulation Therapy System
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Applicant
- Medtronic, Inc.
- Date received
- 2018-10-30
- Decision date
- 2018-11-08
- Days to decision
- 9 days
- Decision code
- OK30
- Product code
- MHY
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Consolidate the laser weld pull strength monitoring tests for four model families into one group (affected models: 977A160, 977A175, 977A190, 977A260, 977A275, 977A290, 977D160, 977D260, 3776, 3777, 3778, 37081, 37082, 37083, 37085, 37086).
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510(k) clearances by this applicant
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|---|---|---|
| VitalFlow Set with Balance™ Biosurface (K261335) | Medtronic, Inc. | 2026-07-31 |
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| Concerto Versa™ Detachable Coil (K253511) | Medtronic, Inc. | 2026-01-14 |
| C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48) (K253409) | Medtronic, Inc. | 2025-12-19 |